RECRUITING

Markers of Trajectory in Pediatric CRPS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS. Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.

Official Title

Identifying Markers of Trajectory in Pediatric Complex Regional Pain Syndrome

Quick Facts

Study Start:2018-08-27
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03838107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age between 10 and 17 years old
  2. * Fluent in English
  3. * Diagnosis of CRPS
  4. * Former unsuccessful treatment for CRPS
  5. * Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC.
  6. * Diagnosis of CRPS
  7. * Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic
  8. * Fluent in English
  9. * Child participating in the study
  1. * Weight/size incompatible with MRI scanner
  2. * Identification of brain, neurologic, or severe psychiatric abnormalities beyond those normally associated with chronic pain.
  3. * Documented developmental delays or impairment
  4. * Any MRI contra-indication, including
  5. * Braces, stents, clips, pace-maker or other metal implants affecting the safety of the participants in the scanner and/or the quality of the images
  6. * pregnancy
  7. * claustrophobia

Contacts and Locations

Study Contact

Marie-Eve Hoeppli, PhD
CONTACT
(513)803-1164
marie-eve.hoeppli@cchmc.org
Geraldine Schulze, BSc
CONTACT
(513) 517-0593
Geraldine.Schulze@cchmc.org

Principal Investigator

Robert C Coghill, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Robert C Coghill, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-27
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2018-08-27
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • pediatric complex regional pain syndrome
  • fMRI
  • psychosocial
  • quantitative sensory testing
  • markers

Additional Relevant MeSH Terms

  • Complex Regional Pain Syndromes